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Homeopathy (2003) 92, 8491 r 2003 The Faculty of Homeopathy

doi:10.1016/S1475-4916(03)00006-7, available online at www.sciencedirect.com

ORIGINAL PAPER

The research evidence base for homeopathy: a fresh assessment of the literature
RT Mathie*
Faculty of Homeopathy, 15 Clerkenwell Close, London, EC1R 0AA, UK

Background. The claims made for the clinical effects of homeopathy are controversial. The results of several meta-analyses of clinical trials are positive, but they fail in general to highlight specic medical conditions that respond well to homeopathy. Aims. This review examines the cumulative research from randomised and/or doubleblind clinical trials (RCTs) in homeopathy for individual medical conditions reported since 1975, and asks the question: What is the weight of the original evidence from published RCTs that homeopathy has an effect that is statistically signicantly different from that in a comparative group? Method. Analysis of the 93 substantive RCTs that compare homeopathy either with placebo or another treatment. Results. 50 papers report a signicant benet of homeopathy in at least one clinical outcome measure, 41 that fail to discern any inter-group differences, and two that describe an inferior response with homeopathy. Considering the relative number of research articles on the 35 different medical conditions in which such research has been carried out, the weight of evidence currently favours a positive treatment effect in eight: childhood diarrhoea, brositis, hayfever, inuenza, pain (miscellaneous), sideeffects of radio- or chemotherapy, sprains and upper respiratory tract infection. Based on published research to date, it seems unlikely that homeopathy is efcacious for headache, stroke or warts. Insufcient research prevents conclusions from being drawn about any other medical conditions. Conclusions. The available research evidence emphasises the need for much more and better-directed research in homeopathy. A fresh agenda of enquiry should consider beyond (but include) the placebo-controlled trial. Each study should adopt research methods and outcome measurements linked to a question addressing the clinical signicance of homeopathys effects. Homeopathy (2003) 92, 8491

Keywords: homeopathy; research design; evidence-based medicine; clinical trials

Introduction
To sceptics, homeopathy is an archaic and ineffective method of treatment that proclaims an implausible mode of action. In contrast, the individual and collective experience of homeopathic practitioners

*Correspondence : (new address from April 2003): RT Mathie, Faculty of Homeopathy, Hahnemann House, 29 Park Street West, Luton, Bedfordshire, LU1 3BE, UK. E-mail: rmathie@trusthomeopathy.org Received 19 November 2002; revised 19 December 2002; accepted 6 January 2003

paints a convincing picture of its clinical effectiveness. Homeopathys possible mechanisms of action remain intangible theories, and it will be important ultimately to substantiate these. The principal issues for the present and immediate future, however, are whether there is compelling research evidence that homeopathy actually does exert a remedial effect, and whether such an effect is remedy-specic. What comprises compelling evidence? Many homeopaths are cheerfully sustained by their own successful clinical experience: We know it works, so why do research to prove it? However, if homeopathy truly enables people attain better health, then it is

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vitally important that it achieves much wider respect within medicine at large. To do this, homeopathy must convince sceptics by rigorous research evidence of its clinical effectiveness. It must also face up to the challenge of demonstrating the specic efcacy of at least some of its medicines. These challenges are best met by data obtained from randomised controlled clinical trials (RCTs), where homeopathy is compared to another intervention or with placebo. Some homeopaths throw up their hands in horror at such a proposition, but new research programmes can grow from observational (cohort) studies,1 for example, which can inform later RCTs. A key to success of any study design is that clinical outcome measures must properly reect the wholeperson approach to healthcare that typies homeopathy. Quality of life assessment and other patientcentred measures, for example, may be at least as important as the measurement of biochemical markers or other physical determinants of health status. After all, in an holistic therapy like homeopathy, the individual symptom- (and thus remedy-) picture often does not equate to a named disease, and so it is inappropriate to measure only disease-specic outcomes in such studies. Another vital concern is that any statistically signicant difference/s between treatment groups in trials should not automatically be equated to clinical importance. It is only the latter that truly matters, and this must be properly accommodated in the power calculations (and thus statistical conclusions) connected with clinical trials. The existing homeopathic research literature has not reected this issue well emphasis has been placed on statistical signicance with incomplete regard to the clinical value of any inter-group differences observed. What is the current evidence from which new research in homeopathy can develop? Given the limitations of past research in homeopathy, the optimum question that can be asked of the available evidence base is limited to: What is the weight of the original evidence from published RCTs that homeopathy has an effect that is statistically signicantly different from that in a comparative group? Only since 1975 have rigorous research methods been applied to homeopathy. Prior literature comprised only four minor trials or brief communications.25 The work reported up to 1997 is captured in the comprehensive meta-analysis of placebo-controlled trials of homeopathy published by Linde et al in The Lancet.6 Nearly half the trials cited in that paper showed a homeopathic treatment effect statistically signicantly greater than that of placebo; none of the trials found placebo more effective than homeopathy. The authors concluded that homeopathys clinical effects are not attributable solely to placebo, though they could not single out any medical condition for which homeopathy seemed clearly efcacious.6

Since 1997, some 50 new clinical trials or metaanalyses in homeopathy have been published. Many of these newer trials have essentially the same Null hypothesis: Homeopathy has an effect which is not statistically signicantly different from that of placebo; in effect, the Null hypothesis that was rejected by Lindes meta-analysis. In 2002, the NHS Centre for Reviews and Dissemination based at the University of York, UK, published an overview of all the published systematic reviews and meta-analyses in homeopathic research.7 The authors conclude: There are currently insufcient data ... to recommend homeopathy as a treatment for any specic condition. This statement is hardly distinguishable from one of Lindes conclusions 5 years earlier. There has been a recent increase in the number of research papers that carry the more original Null hypothesis: Homeopathy has an effect which is not statistically signicantly different from that of another active treatment. Such comparative trials of clinical effectiveness are included in the focus of the present review. The present paper reports the total currently available statistical evidence from the published research literature for and against the specic efcacy or clinical effectiveness of homeopathy, based on the frequency with which the above two Null hypotheses have been rejected or not rejected in clinical trials. This is neither a meta-analysis nor a formal systematic reviewthe paucity and heterogeneity of published research in homeopathy limits the value of such formalised approaches. The originality of the present approach lies mainly in the following: (a) it considers the number of individual trials in homeopathy that report outcome statistics, and by type of medical condition studied; (b) it reports only full, published, research papers; (c) it includes comparative as well as placebo-controlled trials. The coverage reects the entire range of medical conditions in which the effects of homeopathy have been the subject of research and, like Linde et al,6 it only includes trials that are randomised and/or double-blinded. Based on my review, I conclude by recommending some opportunities for future research development in homeopathy.

Literature search methods


This review examines all published clinical trials on human subjects that appeared in the literature from 1975 until December 2002, and which compared homeopathic treatment with placebo or with another medication, where a randomised and/or double-blind study design has been used. The analysis includes only full papers reporting original research, and excludes conference proceedings, brief communications, book chapters and theses. Reports of case series, clinical outcomes (cohort) studies and other non-controlled investigations are also excluded. All forms of homeopathic intervention are included, from
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classical to single-remedy and isopathy. Principal information sources were: The National Library of Medicine (Medline); The Cochrane Library; The Centralised Information Service for Complementary Medicine (CISCOM); The British Homoeopathic Library (HomInform); cross-referencing between published papers. Two principal outcomes are identied: Null hypothesis rejected and Null hypothesis not rejected. For papers in the category Null hypothesis rejected, the ndings are classed as either positive (ie for homeopathy) or negative (ie against homeopathy), based on a two-tailed test. A positive trial is one where at least one outcome measure was statistically signicantly improved by homeopathy compared with placebo or alternative treatment (Pr0.05). A negative study is one where homeopathic treatment was statistically signicantly inferior to the compared treatment (placebo, in the two actual cases cited below) in at least one outcome measure (Pr0.05). Null hypothesis not rejected is the conclusion from a study where no signicant inter-group difference in outcome/s is evident (P40.05). In most cases, these conclusions have been based on the authors own reported hypothesis testing; for results obtained in a few less accessible or non-English language papers, a probability of Pr0.05 was equated with a reported odds ratio (795% condence interval) Z1.6 A balance of evidence in favour of one of the above three categories or classes for a given medical condition is concluded if, using simple arithmetic, it contains at least two more papers than the sum of the papers in the other two categories or classes. This approach has been adopted separately for placebo-controlled and comparative trials.

surgery12), the placebo group had a signicantly better clinical response in at least one outcome measure than patients treated with a homeopathic remedy.
Balance of evidence: placebo-controlled trials Examining the relative number of papers published for each of the three categories or classes of evidence, the present weight of evidence favours homeopathic treatment effectiveness in eight conditions:
* * * * * * * *

childhood diarrhoea; brositis (bromyalgia); hayfever/allergic rhinitis; inuenza; pain (of various origins); side-effects of radio-/chemotherapy; sprains; upper respiratory tract infection.

A weight of evidence suggesting homeopathy has no effect above placebo is apparent in three medical conditions:
* * *

headache; stroke; warts.

For the remaining 20 conditions in which studies have been carried out, there is insufcient weight of evidence either to favour or to nd no support for homeopathy (Table 1). Some of these trials are examples of the double positive paradox,13 where a homeopathy group and a placebo group have indistinguishable results but both manifest some clinical improvement.
Balance of evidence: comparative trials There is insufcient evidence either to favour or to nd no support for homeopathy in nine of the 10 medical conditions in which studies have been carried out (Table 1). Within the group of conditions upper respiratory tract infection, however, a weight of evidence suggests that homeopathy and conventional medicine (aspirin in both papers concerned) are equally effective in treating the common cold.14,15

Results of literature search and analysis


The database scrutinised and reported here comprises a total of 93 original articles in homeopathic research. Of this total, 79 trials were placebo-controlled, while the remaining 14 compared homeopathy with a conventional medical treatment (controlled comparative trials). Table 1 lists all those medical conditions (35 in total), in 11 broad types, for which there exists at least one published clinical research trial in homeopathy that satises the inclusion criteria for this analysis. Given the above criteria, 52 of the total 93 published papers are in the category Null hypothesis rejected (Table 1); the remaining 41 papers are thus in the category Null hypothesis not rejected (ie no conclusive difference between homeopathy and a comparison group). Of the 52 articles, 50 are classed as positive and two are negative. Within the 50 positive reports, 47 observed a homeopathic effect superior to placebo. The three others found homeopathy to be superior to another treatment for the given conditionotitis media,8 osteoarthritis9 and back pain.10 As regards the two negative articles (rheumatoid arthritis,11 tissue healing after dental
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Discussion
Number of published trials in homeopathy The total number of original full research papers over a 27 year time-span (n = 93) is very modest, for research in homeopathy is still in an early stage of development. The largest total number of articles for any particular type of condition is 10 (upper respiratory tract infection). For 12 of the 35 included medical conditions, a single published trial is all that exists. The paucity of research literature is a serious drawback for meta-analyses and formal systematic reviews in homeopathy. In the last 5 years, however,

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Table 1 Medical conditions for which there is at least one published randomised/double-blind clinical research trial in homeopathy Published trials Placebo-controlled Null hypothesis rejected Condition Atopy Cardiovascular Dermatology Asthma Hayfever/allergic rhinitis Hypertension Insect bite-induced erythema Leg ulcers Seborrheic dermatitis Warts Inuenza Otitis media Upper respiratory tract infection ^ Childhood diarrhoea Irritable bowel syndrome Post-operative ileus Female infertility Menopausal syndrome Pre-menstrual syndrome Tissue recovery after childbirth Fibrositis (bromyalgia) Muscle soreness/stiffness/ cramps Osteoarthritis Rheumatoid arthritis Sprains Anxiety Attention-decit hyperactivity disorder Headache Migraine Stroke Vertigo Pain (miscellaneous) Minor burns Miscellaneous tissue trauma Radiotherapy/chemotherapy (side effects) Supercial bruising Cholera Malaria Total Total 4 9 2 2 1 1 2 2 2 10 3 2 3 1 1 2 1 2 5 4 5 2 1 1 2 3 2 1 7 1 3 3 1 1 1 93 47 2 147 150 253,54 128 75561 36365 166 268, 69 + 2 63641
32,33

Comparative Null hypothesis rejected + Null hypothesis not rejected* 7 144 146

Null hypothesis not rejected 7 2 242,43 145 148 149 251,52


34,35

Ear Nose & Throat

62

18

214,15

Gastroenterology

167 170 171 172

Gynaecology

173 276,77 278,79 38688 290,91 192 193 196 111

174 175 38082 183 189 19

Musculo-skeletal

284,85

Neurology and Mental Health

294,95 297,98 299,100 1106 112 1108 1110 1114 1115 30 3 0 110

1101 1107

Pain Tissue trauma

4102105 1109 3111113

Tropical disease

1116 11

References cited by superscript beside the number of articles published. Key to symbols: * Two studies set up formally as equivalence trials.44,101 + positive trial; negative trial; 7 inconclusive trial; ^includes common cold, cough, sinusitis and pharyngitis.

such syntheses of (usually very few) published trials have provided support for homeopathic treatment in hayfever,16 post-operative ileus17 and rheumatoid arthritis.18 Other meta-analyses or systematic reviews have concluded there is insufcient evidence for or against homeopathy in asthma,19 inuenza,20 muscle soreness,21 osteoarthritis,22 prophylaxis for migraine or headache23 and in tissue trauma treated with Arnica.24 Publication bias towards the reporting of positive homeopathic treatment effects has been a wellfounded concern, and is properly recognised in metaanalyses,6,25,26 though no single trial is individually

suspected of biased reporting.27 There is thus very likely to be overall exaggeration of reported positive treatment effects in the homeopathic research literature cited in the present review.
Quality of published trials in homeopathy This review deliberately does not categorise published trials in homeopathy by their intrinsic scientic quality, for information on this issue is already available. Only 29% of placebo-controlled trials in homeopathy published before 1997 were judged to possess high methodological quality.6 A statistical re-evaluation
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of Lindes meta-analysis noted that treatment effects were larger in smaller studies and in those with inadequate blinding of outcome assessment.27 Exaggeration of treatment effect can also be expected in the 14 comparative trials highlighted in the present review: the sample sizes of these 14 studies (mean, 97 patients; range, 10184) are broadly equivalent to those for placebo-controlled trials reported by Linde et al (118; 51270).6 An example of some of the key issues can be taken from the two studies that have examined the effectiveness of homeopathy in otitis media in children. In the rst of these papers, more patients on homeopathy than those on standard care were found to have a normal tympanogram after a treatment period of 12 months.8 The second article reported decreased symptom scores in acute otitis media after 24 and 64 h in patients receiving homeopathy compared with those given placebo.28 These were the only statistically signicant effects observed in either investigation. Both studies were preliminary in nature and had small sample sizes33 and 75 patients, respectively. Both study designs involved randomisation of patients, but of course the comparative trial was not doubleblinded.8 The intrinsic quality of these studies is higher than average in the homeopathic research literature.
Balance of research evidence The above caveats (low volume, publication bias, low quality) are important in considering the research evidence base of homeopathy. Nevertheless, positive effects of homeopathic treatment are apparent in 50 published trials (over half of the included research literature). This represents a body of research where, for at least one outcome measure per trial, the Null hypothesis has been rejected in favour of homeopathy. Three of the papers (in otitis media, osteoarthritis and back pain) provide research evidence that homeopathy can actually be superior to conventional treatment.810 Only two trials have found homeopathy to have less effect than placebo. Based on the relative number of placebo-controlled studies with positive results, the balance of research evidence currently favours homeopathy in childhood diarrhoea, brositis, hayfever, inuenza, pain, sideeffects of radio-/chemotherapy, sprains and upper respiratory tract infection. Based on published research to date, it seems unlikely that homeopathy is efcacious for headache, stroke or warts. Insufcient research in 20 medical conditions prevents clear conclusions from being drawn. There has been no research at all in homeopathy for many other ailments. It is thus not surprising that comprehensive meta-analyses or systematic reviews in homeopathy have not discerned any clear pattern of medical conditions that appear especially promising for effective homeopathic intervention.29 Meanwhile, homeopathic practitioners continue to chronicle their successful clinical cases.30
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Future opportunities and direction in homeopathic research Key issues that must be addressed in future research development in homeopathy include: the research question, the associated trial design and the outcome measures chosen. Fresh research should consider carefully whether placebo-controlled trials and physical determinants of health are necessarily the wisest approach. Such approaches may be particularly inappropriate in researching homeopathy for chronic illness or where the treatment does not address a named disease. Conditions of this nature are nearly always treated by individualised homeopathy, where remedy selection is based on a persons constitutional character, and so non-placebo-controlled designs using quality of life measures, for example, might be the most relevant. The most appropriate place for placebocontrolled trials in homeopathy might be in examining acute (as opposed to chronic) medical conditions, where any homeopathic treatment effect is likely to be swift acting, and thus better discernable. The fact that prescribing is relatively simple (minimal range of indicated remedies) in some acute conditions could offer useful advantages in study design. It may be noteworthy that acute, rather than chronic, conditions feature prominently among those for which homeopathy has the greatest weight of positive research evidence in placebo-controlled trials. Investigators might also consider testing the effects of homeopathy as an adjunct to conventional medication, thus reecting its complementary nature. Equivalence trials offer another promising way forward. In these, a conclusion of similar clinical outcome between homeopathy and an orthodox treatment would be based on an ability to accept statistically equivalent condence intervals in the two groups of data.31 This approach would be greatly preferable to assuming equivalence based merely on failure to reject the Null hypothesis in a typical superiority trial, as is the case in nearly all of the 41 examples presented here. Formal equivalence trials could enable researchers to examine more robustly the relative safety and cost-effectiveness of homeopathy compared with a conventional medicine that was shown to possess similar treatment effectiveness in a particular clinical situation. It remains to be seen whether passage of time sees the publication of increased numbers and quality of published research papers relevant to homeopathy that report clinically signicant ndings in its favour. For its practitioners, such robust research data would have an important impact in improving the credibility as well as the intrinsic quality of the homeopathy that they provide to their patients.

Acknowledgements
It is a pleasure to thank Conrad Harris, Peter Fisher and Bob Leckridge for their helpful comments on the manuscript in the early stages of its preparation.

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J Am Inst Homeopath 1994; 87: 1421. 75 Hofmeyr GJ, Piccioni V, Blauhof P. Postpartum homoeopathic Arnica montana: a potency-nding pilot study. Br J Clin Pract 1990; 44: 619621. 76 Fisher P. An experimental double-blind clinical trial method in homoeopathy. Use of a limited range of remedies to treat brositis. Br Hom J 1986; 75: 142147. 77 Fisher P, Greenwood A, Huskisson EC, et al. Effect of homeopathic treatment on brositis (primary bromyalgia). Br Med J 1989; 299: 365366. 78 Tveiten D, Bruseth S, Borchgrevink CF, Norseth J. Effects of the homoeopathic remedy Arnica D30 on marathon runners: a randomized, double-blind study during the 1995 Oslo Marathon. Complement Ther Med 1998; 6: 7174. 79 Hariveau E. La recherche clinique a linstitut Boiron. ! Homeopathie 1987; 5: 5558. 80 Schmidt C. A double-blind, placebo-controlled trial: Arnica montana applied topically to subcutaneous mechanical injuries. J Am Inst Homeopath 1996; 89: 186193. 81 Jawara N, Lewith G, Mullee M, et al. Homoeopathic Arnica and Rhus Toxicodendron for delayed onset muscle soreness: a randomised, double-blind, placebo-controlled trial. Br Hom J 1997; 86: 1015. 82 Vickers AJ, Fisher P, Smith C, et al. Homeopathic Arnica 30x is ineffective for muscle soreness after long-distance running: a randomized, double-blind, placebo-controlled trial. Clin J Pain 1998; 14: 227231. 83 Shipley M, Berry H, Broster G, et al. Controlled trial of homoeopathic treatment of osteoarthritis. Lancet 1983; i: 9798. 84 Nahler G, Metelmann H, Sperber H. Treating osteoarthritis of the knee with a homeopathic preparation: results of a randomized, controlled, clinical trial in comparison to hyaluronic acid. Biomed Ther 1998; 16: 186191. 85 Shealey CN, Thomlinson RP, Cox RH, Borgmeyer V. Osteoarthritic pain: a comparison of homeopathy and acetaminophen. Am J Pain Manage 1998; 8: 8991. 86 Gibson RG, Gibson SL, MacNeill AD, Buchanan WW. Homoeopathic therapy in rheumatoid arthritis: evaluation by double-blind clinical therapeutic trial. Br J Clin Pharmacol 1980; 9: 453459. 87 Wiesenauer M, Gaus W. Wirksamkeitsnachweis eines Hom. oopathikums bei chronischer Polyarthritis. Eine randomi. sierte Doppelblindstudie bei niedergelassenen Arzten. Akt Rheumatol 1991; 16; 19.

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Research evidence for homeopathy RT Mathie

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. . 88 Kohler T. Wirksamkeitnachweis eines Homoopathikums bei chronischer Polyarthritis - eine randomisierte Doppelblind. studie bei niedergelassenen Arzten. Der Kassenarzt 1991; 13: 4852. 89 Andrade LE, Ferraz MB, Atra E, et al. A randomized controlled trial to evaluate the effectiveness of homeopathy in rheumatoid arthritis. Scand J Rheumatol 1991; 20: 204208. . 90 Bohmer D, Ambrus P. Behandlung von Sportverletzungen mit Traumeel-SalbeKontrollierte Doppelblindstudie. Biol Med 1992; 21: 260268. 91 Zell J, Connert WD, Mau J, Feuerstake G. Treatment of acute sprains of the ankle joint. Double-blind study assessing the effectiveness of a homeopathic ointment preparation. Fortschr Med 1988; 106: 96100. 92 McCutcheon LE. Treatment of anxiety with a homeopathic remedy. J Appl Nutr 1996; 48: 26. 93 Lamont J. Homoeopathic treatment of attention decit hyperactivity disorder. A controlled study. Br Hom J 1997; 86: 196200. 94 Gaus W. Biometrische Aspekte der Munchener Kopfschmerzstudie Allgem. Homoopath Zeit 1997; 242: 245249. . 95 Walach H, Haeusler W, Lowes T, et al. Classical homeopathic treatment of chronic headaches. Cephalalgia 1997; 17: 119126. 96 Brigo B, Serpelloni G. Homeopathic treatment of migraines: a randomized double-blind controlled study of sixty cases (homeopathic remedy versus placebo). Berlin J Res Homoeopath 1991; 1: 98106. 97 Whitmarsh TE, Coleston-Shields DM, Steiner TJ. Doubleblind randomized placebo-controlled study of homoeopathic prophylaxis of migraine. Cephalalgia 1997; 17: 600604. 98 Straumsheim P, Borchgrevink C, Mowinckel P, et al. Homeopathic treatment of migraine: a double blind, placebo controlled trial of 68 patients. Br Hom J 2000; 89: 47. 99 Savage RH, Roe PF. A double blind trial to assess the benet of Arnica montana in acute stroke illness. Br Hom J 1977; 66: 207220. 100 Savage RH, Roe PF. A further double blind trial to assess the benet of Arnica montana in acute stroke illness. Br Hom J 1978; 67: 210222. 101 Weiser M, Strosser W, Klein P. Homeopathic vs conventional treatment of vertigo: a randomized double-blind controlled clinical study. Arch Otolaryngol Head Neck Surg 1998; 124: 879885. " 102 Dorfman P, Lasserre MN, Tetau M. Pr! paration a laccoue chement par hom! opathieexperimentation en double insu e versus placebo. Cahiers Bioth!rap 1987; 94: 7781. e 103 Dorfman P, Amodeo C, Riccioti F, et al. Evaluation de lactivit! darnica 5CH sur les troubles veineux apr" s perfusion e e prolong! e. Cahiers Bioth!rap 1988; 98(Suppl): 7782. e e 104 Ernst E, Saradeth T, Resch KL. Complementary treatment of varicose veinsa randomized, placebo-controlled, doubleblind trial. Phlebology 1990; 5: 157163. 105 Jeffrey SL, Belcher HJ. Use of Arnica to relieve pain after carpal-tunnel release surgery. Altern Ther Health Med 2002; 8: 6668. 106 Hart O, Mullee MA, Lewith G, Miller J. Double-blind, placebo-controlled, randomized clinical trial of homoeopathic arnica C30 for pain and infection after total abdominal hysterectomy. J R Soc Med 1997; 90: 7378. 107 Stam C, Bonnet MS, van Haselen RA. The efcacy and safety of a homeopathic gel in the treatment of acute low back pain: a multi-centre, randomised, double-blind comparative clinical trial. Br Hom J 2001; 90: 21-28. 108 Leaman AM, Gorman D. Cantharis in the early treatment of minor burns. Arch Emerg Med 1989; 6: 259261. 109 Chapman EH, Weintraub RJ, Milburn MA, et al. Homeopathic treatment of mild traumatic brain injury: a randomized, double-blind, placebo-controlled clinical trial. J Head Trauma Rehabil 1999; 14: 521542. . 110 Lokken P, Straumsheim PA, Tveiten D, et al. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. Br Med J 1995; 310: 14391442. 111 Balzarini A, Felisi E, Martini A, De Conno F. Efcacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial. Br Hom J 2000; 89: 812. 112 Kulkarni A, Nagarkar BM, Burde GS. Radiation protection by use of homoeopathic medicines. Hahnemann Homoeopath Sand 1998; 12: 2023. 113 Oberbaum M, Yaniv I, Ben-Gal Y, et al. A randomized, controlled clinical trial of the homeopathic medication Traumeel S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer 2001; 92: 684690. 114 Campbell, A. Two pilot controlled trials of Arnica montana. Br Hom J 1976; 65: 154158. 115 Gaucher C, Jeulin D, Peycru P, Amengual C. A double blind randomized placebo controlled study of cholera treatment with highly diluted and succussed solutions. Br Hom J 1994; 83: 132134. 116 van Erp VM, Brands M. Homoeopathic treatment of malaria in Ghana: open study and clinical trial. Br Hom J 1996; 85: 6670.

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